{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-08-20",
    "results": {
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  "results": [
    {
      "cfres_id": "141982",
      "product_res_number": "Z-0452-2016",
      "event_date_initiated": "2015-11-10",
      "event_date_posted": "2015-12-21",
      "recall_status": "Terminated",
      "event_date_terminated": "2016-02-19",
      "res_event_number": "72688",
      "product_code": "HAB",
      "product_description": "Zimmer UNIVERSAL Power System Loaner and Modular Electric/Battery Double Trigger Handpiece. Rx only Made in Switzerland",
      "code_info": "Model # 01-8507-400-00 & Model # 89-8507-400-00",
      "firm_fei_number": "1000220733",
      "recalling_firm": "Zimmer, Inc.",
      "address_1": "1800 W Center St",
      "city": "Warsaw",
      "state": "IN",
      "postal_code": "46580-2304",
      "additional_info_contact": "800-613-6131",
      "reason_for_recall": "The firm identified a malfunction which made it possible for a handpiece to start by itself when the power source is connected.",
      "root_cause_description": "Device Design",
      "action": "Zimmer sent an Urgent Medical Device Correction letter dated November 9, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.\n\n1. Review this notification.\n2. You will receive copies of notification sent directly to hospital risk managers and surgeons in your territory.  As necessary, review and facilitate understanding of this notification by those entities.\n3. Further identify hospital risk managers and/or surgeons in your territory who should also receive notification of this update, and supply the information to the entities you have identified.\n4. If after reviewing this notification you have further questions or concerns, please call 330-364-0989 between the hours of 8 a.m. and 5 p.m. EST, Monday through Friday.\n\nZimmer instructed their direct customers that they will upgrade the device with the new electronic during their annual preventative maintenance activities.  Until the new upgrade is installed, the firm instructed their customers to follow the Instructions for Use.",
      "product_quantity": "87",
      "distribution_pattern": "US Distribution to the states of :  AR, CA, CO, CT, FL, GA, HI, IL, KS, KY, LA, ME, MI, MN, MO, MS, NC, NE, NJ, NV, NY, OH, PA, RI, SC, TX, UT, VA, WA, WI, WV and WY.",
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        "device_name": "Saw, Powered, And Accessories",
        "medical_specialty_description": "General, Plastic Surgery",
        "regulation_number": "878.4820",
        "device_class": "1"
      }
    }
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}